NCT04764890

Brief Summary

The aims of the study are: To study the pain efficacy of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica. To study the efficacy on function of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 19, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 16, 2021

Last Update Submit

April 16, 2021

Conditions

SciaticaElectroacupunctureManual Therapy

Outcome Measures

Primary Outcomes (2)

  • Visual analog scale for pain

    Pain measurement: 100-mm visual analog scale (VAS), horizontal line ranging from 0 mm (nopain) to 100 (worts imaginable pain)

    up to 5 weeks

  • Oswestry Low Back Pain Disability Questionnaire

    This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.

    up to 5 weeks

Study Arms (2)

Electroacupuncture and manual therapy

EXPERIMENTAL

Electroacupuncture in several points and manual therapy in the lumbar spine

Other: ElectroacupunctureOther: Manual therapy

Manual therapy

ACTIVE COMPARATOR

Manual therapy in the lumbar spina

Other: Manual therapy

Interventions

ElectroacupunctureOTHER

Electroacupuncture in several point

Electroacupuncture and manual therapy
Manual therapyOTHER

Manual therapy in the lower spine.

Electroacupuncture and manual therapyManual therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged from 18 to 50 years old.
  • Diagnosis of sciatica

You may not qualify if:

  • Pregnancy.
  • Fear of needles.
  • Coagulation disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEU-San Pablo Universtiy

Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Sciatica

Interventions

ElectroacupunctureMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Central Study Contacts

Juan Carlos Zuil Escobar, PhD

CONTACT

+3491372400jczuil@ceu.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Electroacupuncture and manual therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 21, 2021

Study Start

February 11, 2021

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

April 19, 2021

Record last verified: 2021-02

Locations

ES(1)